Olympus recalls GF-UCT140-AL5 ultrasound endoscopes due to updated cleaning instructions potentially increasing infection risk during medical procedures.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Olympus is recalling ultrasound endoscopes used in gastrointestinal procedures because recent cleaning instructions might increase infection risks. This affects medical professionals who use the device with other equipment.
The recall involves updated cleaning instructions that could theoretically increase infection risks if not followed correctly. This is a procedural change to reduce infection risks during medical procedures.
Medical professionals who use Olympus Ultrasound Endoscopes (model GF-UCT140-AL5) for gastrointestinal procedures are most at risk. The recall applies to all units sold with serial/lot numbers.
Check for the model number GF-UCT140-AL5 on the endoscope. The product is used with other equipment for endoscopic ultrasound imaging and surgery in the gastrointestinal tract.
Check the current Instructions For Use (IFU) for the device to ensure you follow the updated cleaning steps.
The recall is about updated cleaning instructions to reduce infection risks, not a safety issue with the device itself.
No, the recall does not require stopping use; it involves following updated cleaning procedures.
Review the cleaning instructions in the current Instructions For Use (IFU) to ensure proper infection control.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0499-2021 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
